The role of solidarity and subsidiarity for unions in healthcare.
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Biomedical subjects
Publications and source records attributed to G Magill.
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Organizational ethics refers to the integration of values into decision making, policies, and behavior throughout the multi-disciplinary environment of a health care organization. Based upon Catholic social ethics, stewardship is at the heart of organizational ethics in health care in this sense: stewardship provides the hermeneutic filter that enables basic ethical principles to be realized practically, within the context of the Catholic theology of work, to concerns in health care. This general argument can shed light on the specific topic of non-executive compensation programs as an illustration of organizational ethics in health care.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
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Previous pharmacological and clinical data have suggested that it is possible to increase significantly the dose of "active" cisplatin delivered systemically by the simultaneous administration of intravenous sodium thiosulfate. In order to define more critically the toxicity and potential efficacy of this therapeutic approach, 36 patients with a variety of solid tumors and limited pretreatment were entered into a phase-1 trial of high-dose intravenous cisplatin plus sodium thiosulfate. The maximally tolerated dose of cisplatin was found to be 200 mg/m2, excessive renal toxicity being observed at a dose of 225 mg/m2 (6/14 courses associated with serum creatinine rise to greater than 2.0 mg-%). Following several courses of high-dose cisplatin, peripheral neuropathy becomes the limiting toxicity (9/15 patients receiving at least three courses of cisplatin at greater than or equal to 150 mg/m2 experienced at least grade-1 neuropathy). Significant ototoxicity developed after only one or two treatment courses, but with continued treatment hearing loss appeared to stabilize in the moderately severe range in most patients. Major responses (PR/CR) were observed in 7/27 evaluable patients. We conclude that cisplatin can be administered at a dose at 200 mg/m2 as a 2-h infusion (with simultaneous sodium thiosulfate) with significant but acceptable toxicities and without evidence of loss of anti-neoplastic activity (secondary to the presence of thiosulfate). However, owing to the development of neurotoxicity most patients will be unable to receive more than three courses of this high-dose treatment regimen.
Twenty-five previously untreated patients with advanced adenocarcinoma of the upper gastrointestinal tract were treated with a combination of carboplatin and vinblastine. Two partial responses (duration three months and six months) were seen among 22 evaluable patients. Myelosuppression was the most common toxicity and was generally mild. The 8% response rate, (95% confidence interval 2 to 24%) observed in this study indicated that carboplatin-vinblastine has only modest activity in adenocarcinoma of the upper gastrointestinal tract. Although less toxic, this regimen appears to be less effective than previously reported cisplatin-containing regimens in adenocarcinoma of the upper GI tract.
Iproplatin (CHIP) is a second generation cisplatin analogue which has completed its Phase I trials. We studied the efficacy and toxicity of CHIP in 36 previously untreated patients with advanced upper gastrointestinal tract adenocarcinomas (GE junction, cardia, antrum and body of the stomach). The starting dose was 275 mg/m2; course were repeated on an every four week schedule. Thirty-five patients were evaluable for response. Three partial remissions (8.5%) [95% confidence limits 2.5-15%] were seen. Toxicity was tolerable and included mild myelosuppression and mild nausea and vomiting. Although well tolerated, in patients with gastric and GE junction adenocarcinomas, CHIP chemotherapy was not more and probably slightly less, effective than the parent analogue cisplatin.
In a phase I-II study, 28 patients with advanced pancreatic adenocarcinoma were treated with cisplatin, high-dose cytarabine (ARA-C), and caffeine. This clinical trial was based on a nude mouse-human tumor xenograft model, which demonstrated synergism of these agents by inhibiting the growth of human pancreatic tumors. Toxic effects noted in the clinical study included myelosuppression, moderate nausea and vomiting, and mild renal insufficiency. No toxic effects were directly attributable to caffeine. Eighteen of the 28 patients had measurable or assessable disease; seven (39%) had partial responses (95% confidence intervals, 18%-63%). The median response duration was 6.2 months. Median survival for responders was 9.5 months with two patients surviving for more than 18 months. Median survival for all patients was 6.1 months. The combination of cisplatin, ARA-C, and caffeine is an active and tolerable regimen in the treatment of advanced pancreatic cancer. A phase III trial in which this regimen is being compared with standard therapy is in progress.
We conducted a prospective randomized study of the benefit of adjuvant radiation therapy delivered by the brachytherapy technique in 117 adult patients who had soft-tissue sarcoma that was on an extremity or superficially localized to the trunk. A significant decrease in local recurrence was demonstrated in the patients receiving brachytherapy. The benefit did not appear to be due to any maldistribution in the known prognostic factors of size, site, depth, presentation with recurrence, or histologic grade. The decrease in local recurrence appears to be due to the decreased local recurrence in high-grade sarcomas. Survival differences were not identified, and accrual and follow-up were continued.
Thirty-three patients with advanced, metastatic APUD tumors (islet cell, carcinoid, or medullary carcinomas of the thyroid) were treated with etoposide as a single agent. Of 29 evaluable patients, four (14%) had partial responses (95% confidence limits, 1%-26%). Toxic effects seen were those previously reported for etoposide as a single agent. Etoposide has activity in APUD tumors; further studies with this agent are indicated.
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From 1972 to 1983, we treated 78 patients who had primary epidermoid carcinoma of the anus. Forty-four of these patients were treated by protocol, while 34 patients were not treated according to protocol. Protocol consisted of fluorouracil (750 mg/m for 5 days) and mitomycin (10 to 15 mg/m on day 1), followed sequentially by 3000 rad (30 Gy) over three weeks, followed by surgery. There were 20 local excisions and 29 abdominoperineal resections in the protocol group, and 11 local excisions and 14 abdominoperineal resections in the nonprotocol group. In the protocol group, 26 patients (59%) had no residual cancer in their operative specimens, while only ten (29.9%) of the nonprotocol patients had no remaining cancer. Four (11.7%) of the 34 nonprotocol patients had pathologically positive inguinal nodes, compared with only three (4.5%) of 44 protocol patients. Thirty-four (77%) of 44 protocol patients remained free of disease, while ten patients experienced local or pelvic recurrence. In contrast, only 17 (50%) of 34 patients in the nonprotocol group remained free of disease. Of 17 recurrences, five were at distant sites. The status at this writing of all patients in the protocol group was 32 (75%), with no evidence of disease, four alive with disease, and eight dead of or with disease. Of the untreated patients, only 11 (32%) remained without evidence of disease, two were alive with disease, and 19 were dead of or with disease. Smaller carcinoma size (less than 5 cm, 27 of 32 had no evidence of disease), younger age, female gender, and deep infiltration also predicted a statistically significant survival advantage after protocol treatment. Controlled, prospective, multi-institutional trials should stratify for these factors when comparing new treatment modalities.
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Adenocarcinoma of unknown primary origin (ACUP) is a common oncologic problem for which there is no standard therapy. Forty-two patients with metastatic tumor were identified as having ACUP after extensive evaluation failed to reveal a primary site of disease. They were treated with an investigational chemotherapy regimen consisting of vindesine and doxorubicin. Of the 38 evaluable patients, six (16%) had major responses to chemotherapy. The median duration of response was 4 months. The median survival of the responding patients has not been reached, but is greater than 8 months. The median survival of the nonresponding patients was 6 months. Vindesine and doxorubicin were well tolerated. The major toxicity was leukopenia, with a median wbc count nadir of 2600/mm. We conclude that the combination of vindesine and doxorubicin has some activity in ACUP, but does not improve the response rate seen with other regimens.